A Phase 1 Study With Expansion of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (PANACEA)
Marker Therapeutics, Inc.
Summary
The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question\[s\] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.
Description
The Dose Escalation portion of the study will use a modified 3+3 design to define an acceptable dose of MT-601 in combination with maintenance capecitabine following completion of FFX or NLX chemotherapy. For the Dose Expansion, MT-601 will be administered at the dose determined to be safe based on the results from the Dose Escalation portion. Front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) will be administered as per standard of care. MT-601 will be administered intravenously over no less than 5 minutes as a single dose following completion of all planned doses of FFX or NL…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Informed Consent 2. Age ≥ 18 years 3. ECOG performance status of 0 to 1 4. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included). 5. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 6. Prior receipt of at least 4 doses (\~2 months) of FFX or NLX with plans for completion of 12 doses (\~6 months) 7. Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry)…
Interventions
- DrugMT-601 dose 200 million cells
MT-601 Dose 200 million cells
- DrugMT-601 dose 400 million cells
MT-601 Dose 400 million cells
- DrugMT-601 dose 800 million cells
MT-601 Dose 800 million cells
- DrugMT-601 dose 1200 million cells
MT-601 Dose 1200 million cells
Location
- The University of Texas MD AndersonHouston, Texas